Evidence map›Paper›PMID 33492568›Full record

Trial reportTargeted oncology2021

A Randomized Phase I Study of Abemaciclib in Chinese Patients with Advanced and/or Metastatic Cancers.

Jian Zhang, Nong Yang, Dongmei Ji, Weina Shen, Wenhua Li, Rubing Han, Ning Wang, Haoxun Tao, Sonya C Chapman, Amanda K Sykes and 2 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Targeted oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02919696 (A Phase 1 Study of Abemaciclib in Native Chinese Patients With Advanced and/or Metastatic Cancers), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.7field-weighted citation impact, top 27% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02919696 phase1completednot on this map

A Phase 1 Study of Abemaciclib in Native Chinese Patients With Advanced and/or Metastatic Cancers

TypeinterventionalSponsorEli Lilly and CompanyRan2017 to 2019Enrolled26ConditionsAdvanced Cancer, Metastatic CancerArmsAbemaciclib
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 9 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Article
  6. Review
  7. A narrative review of the clinical development of CDK4/6 inhibitor abemaciclib in breast cancer.Translational breast cancer research : a journal focusing on translational research in breast cancer · 2022
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 4 institutions in 2 countries.

Jian Zhang *Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Nong Yang *Department of Medical Oncology, Hunan Cancer Hospital, Changsha, China.
Dongmei JiDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Weina ShenDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Wenhua LiDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Rubing HanEli Lilly and Company, Shanghai, China.
Ning WangEli Lilly and Company, Shanghai, China.
Haoxun TaoEli Lilly and Company, Shanghai, China.
Sonya C ChapmanEli Lilly and Company, Windlesham, UK.
Amanda K SykesEli Lilly and Company, Windlesham, UK.
Wanli ZhangEli Lilly and Company, Shanghai, China.
Xichun HuDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. xchu2009@hotmail.com.
Fudan University Shanghai Cancer Center · CNLilly (China) · CNEli Lilly (United Kingdom) · GBHunan Cancer Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAbemaciclib, a cyclin-dependent kinase 4 and 6 inhibitor, is approved in combination with endocrine therapy or as monotherapy for hormone receptor-positive and human epidermal growth factor receptor-2-negative (HR+/HER2-) advanced breast cancer outside of China.

objectiveTo evaluate the safety, tolerability, and pharmacokinetic (PK) profile of abemaciclib in Chinese patients with advanced and/or metastatic cancers. PATIENTS AND

methodsA multicenter, open-label, phase I trial of abemaciclib in Chinese patients with advanced and/or metastatic cancers was conducted. Patients were randomized (1:1) to oral abemaciclib 150 or 200 mg every 12 h on a 28-day cycle. Safety analyses (primary outcome) included all patients receiving at least one dose of abemaciclib. PK and antitumor activity were also assessed.

resultsOf the 26 patients randomized, 25 received abemaciclib 150 mg (n = 12) or 200 mg (n = 13). All 25 patients reported ≥ 1 treatment-emergent adverse event (TEAE). The majority of TEAEs were Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or 2 in severity. The most frequent TEAEs of Grade ≥ 3 were neutropenia (32%) and thrombocytopenia (24%). Four patients (16%) discontinued treatment due to AEs. Abemaciclib exhibited slow absorption and clearance at single dose, with maximum concentrations achieved after around 6 h and an elimination half-life of approximately 24 h. No complete response was observed, two patients (8%) achieved partial response, with one confirmed responder, and the disease control rate was 68% (n = 17).

conclusionsAbemaciclib was well tolerated and the safety and PK profiles in Chinese patients were comparable to those previously reported in non-Chinese populations. Preliminary antitumor activity was observed. CLINICALTRIALS. GOV IDENTIFIER: NCT02919696.

Indexed as

AgedAminopyridinesBenzimidazolesChinaFemaleHumansMaleNeoplasm MetastasisNeoplasmsabemaciclibAminopyridinesBenzimidazoles

Identifiers

PMID33492568
PMCPMC7935732
OpenAlexW3194125188

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.